Study on Bioequivalence of 2 Kinds of Memantine Tablets in Healthy Volunteers

OBJECTIVE:To evaluate the relative bioavailability and bioequivalence of 2 kinds of Memantine tablets from different manufacturers.METHODS:In standard two step cross-design self-controlled trials,20 healthy male volunteers were randomly divided into 2 groups.2 groups orally took a single dose of 10 mg tablets of the test preparation (domestic tablet) and reference preparation (imported tablet).The plasma concentration of memantine was determined by LC-MS,and pharmacokinetic parameters were calculated by using DAS 2.0 software.RESULTS:The pharmacokinetic parameters of reference and test preparations were as follows:t1/2 were (69.77±14.61)h vs.(76.06±17.92)h;tmax(5.15±1.18)h vs.(5.05±1.36)h;cmax(13.64±3.28)μg·mL-1 vs.(13.34±4.18)μg·mL-1;AUC0～240 h(857.73±164.45)μg·h·mL-1 vs.(888.16±316) μg·h·mL-1;AUC0～∞(940.00±180.70)μg·h·mL-1 vs.(999.00±346.40)μg·h·mL-1,respectively.The relative bioavailability of test preparation was 104.2%,compared with reference preparation.CONCLUSION:2 kinds of Memantine tablets are bioequivalent.